Save Article

FDA Requires Added Study
From Forest on Alcohol Pill

Dow Jones Newswires

Updated July 2, 2002 11:45 p.m. ET

WASHINGTON -- The Food and Drug Administration told Forest Laboratories Inc. it must submit an additional study to win U.S. regulatory approval for a pill to treat alcoholism, even though the drug garnered an endorsement in May from a panel of expert federal advisers.

When the FDA panel considered the drug, acamprosate, they questioned the value of two decade-old European studies where all patients were required to have given up drinking. Acamprosate performed better in the European trials than in the 1999 U.S. trial,...